AAMI: Leading Standards for Medical Device Sterilization

The Association for the Advancement of Medical Instrumentation (AAMI) is the primary U.S. standards developer for medical device sterilization, reprocessing, and related quality systems. Its standards are recognized by the FDA and adopted globally.

Key AAMI Sterilization Standards

• ANSI/AAMI ST79: Comprehensive guide to steam sterilization and assurance in healthcare facilities.
• ANSI/AAMI ST58: Chemical sterilization and high-level disinfection.
• ANSI/AAMI ST60: Industrial ethylene oxide sterilization.
• ANSI/AAMI ST67: Requirements for products sterilized by irradiation.
• ANSI/AAMI ST106: Sterilization process validation for medical devices.
• ISO 11135 / ISO 11137 / ISO 17665: International counterparts (AAMI participates as U.S. TAG administrator).

Scope and Impact

• Covers hospitals, ASCs, device manufacturers, contract sterilizers.
• Addresses validation, routine monitoring, packaging, labeling, personnel competency.
• Mandatory for FDA 510(k) and PMA submissions involving sterile devices.
• Updated regularly to reflect technology (e.g., low-temp sterilization, single-use device reprocessing).

AAMI standards ensure sterility assurance, patient safety, and regulatory compliance across the healthcare continuum.